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NCT Number: NCT05047185

Dose-ranging Study of Oral PHA-022121 for Prophylaxis Against Angioedema Attacks in Patients With Hereditary Angioedema Type I or Type II

This study evaluates the safety and efficacy of PHA-022121 administered orally for prophylaxis against angioedema attacks in patients with hereditary angioedema (HAE). The study consists of 2 parts, with patients completing participation in Part 1 prior to initiation of treatment in Part 2. Part 1 of the study has 3 parallel arms and approximately 30 patients will be equally randomized to one of two dose regimens of PHA-022121 or matching placebo. Patients will continue to the single open-label arm in Part 2 of the study after completion of Part 1. The screening period is up to 8 weeks and the treatment periods are 12 weeks (Part 1) and 30 months (Part 2) in duration.

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Key information

Conditions

Hereditary Angioedema Angioedema Angioedemas, Hereditary C1 Esterase Inhibitor Deficiency C1 Inhibitor Deficiency Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hereditary Angioedema - Type 1 Hereditary Angioedema - Type 2 Hereditary Angioedema Attack Hereditary Angioedema Type I Hereditary Angioedema Type II Hereditary Angioedema Types I and II Hereditary Angioedema With C1 Esterase Inhibitor Deficiency Hereditary Complement Deficiency Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Immunologic Deficiency Syndromes Primary Immunodeficiency Diseases Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Urticaria Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Study Site, Vienna, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Signed and dated informed consent form
  • Diagnosis of HAE type I or II
  • Documented history of at least 3 HAE attacks within the last 3 consecutive months prior to screening, or a minimum of 2 HAE attacks during the screening period
  • Reliable access and experience to use standard of care acute attack medications

Exclusion criteria

  • Pregnancy or breast-feeding
  • Clinically significant abnormal electrocardiogram
  • Any other systemic disease or significant disease or disorder that would interfere with the patient's safety or ability to participate in the study
  • Use of C1-esterase inhibitor, oral kallikrein inhibitors, attenuated androgens, anti-fibrinolytics, or monoclonal HAE therapy within a defined period prior to enrolment
  • Abnormal hepatic function
  • Abnormal renal function
  • History of alcohol or drug abuse within defined period, or current evidence of substance dependence or abuse
  • Participation in any other investigational drug study within defined period

Treatment and study plan

Deucrictibant low dose

Drug

Deucrictibant softgel capsules for oral use (PHVS416)

Deucrictibant high dose

Drug

Deucrictibant softgel capsules for oral use (PHVS416)

Placebo

Drug

Matching placebo capsules for oral use

Primary outcomes

  1. Number of investigator-confirmed HAE attacks

    Time frame: Day 0 to Day 84

Secondary outcomes

  1. Number of investigator-confirmed moderate or severe HAE attacks during the treatment period

    Time frame: Day 0 to Day 84

  2. Number of investigator-confirmed HAE attacks requiring acute treatment during the treatment period

    Time frame: Day 0 to Day 84

  3. Number of patients achieving reduction in attack rate during the treatment period relative to baseline

    Time frame: Day 0 to Day 84

  4. Number of patients that are attack-free during the treatment period

    Time frame: Day 0 to Day 84

  5. Number and proportion of days with angioedema symptoms during the treatment period

    Time frame: Day 0 to Day 84

  6. Time to first investigator-confirmed HAE attack in the treatment period

    Time frame: Day 0 to Day 84

  7. Number of investigator-confirmed HAE attacks resulting in a visit to the emergency department or an admission to hospital

    Time frame: Day 0 to Day 84

  8. Number of investigator-confirmed angioedema attacks during the treatment period in Part 2.

    Time frame: Day 84 to Day 938

  9. Number of investigator-confirmed moderate or severe angioedema attacks during the treatment period in Part 2.

    Time frame: Day 84 to Day 938

  10. Number of investigator-confirmed angioedema attacks requiring acute treatment during the treatment period in Part 2.

    Time frame: Day 84 to Day 938

  11. Incidence of HAE attacks during the treatment period in Part 2 (attack rate trend over time).

    Time frame: Day 84 to Day 938

  12. Number and proportion of days with angioedema symptoms during the treatment period in Part 2.

    Time frame: Day 84 to Day 938

Sponsors and collaborators

Lead sponsor

Pharvaris Netherlands B.V.

Industry

Registry information

Official study title

A Phase II, Double-blind, Placebo-controlled, Randomized, Dose-ranging, Parallel Group Study to Evaluate the Safety and Efficacy of PHA-022121 Administered Orally for Prophylaxis Against Angioedema Attacks in Patients With Hereditary Angioedema Due to C1-Inhibitor Deficiency (Type I or Type II)

Acronym: HAE CHAPTER-1

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Sep 17, 2021
Registry last updated
Jul 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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